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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K182002
Device Name Cumulus Remover
Applicant
Kitazato Corporation
81 Fuji
Shizuoka,  JP 416-0907
Applicant Contact Futoshi Inoue
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Audrey Swearingen
Regulation Number884.6180
Classification Product Code
MQL  
Date Received07/26/2018
Decision Date 10/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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